FDA.reportPublic FDA data

FLUOCINOLONE ACETONIDE

Product NDC
70752-159
11-digit product format
707520159
Labeler code
70752
Product ID
70752-159_c2b257ee-da2e-4af6-908a-aeb4838e698e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Quagen Pharmaceuticals LLC
Application
ANDA212762
Marketing category
ANDA
Marketing start
2021-04-02
Substance
FLUOCINOLONE ACETONIDE
Active strength
.11 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLUOCINOLONE ACETONIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191299

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70752-159-202023-02-26C16284748780-1f386c649-bbfe-0266-e053-dadaa90a7c1aFluocinolone Acetonide Oil, 0.01% (Ear Drops)
70752-159-202023-01-30C16284748780-1f386c649-bbfe-0266-e053-dadaa90a7c1aFluocinolone Acetonide Oil, 0.01% (Ear Drops)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70752-159-20FLUOCINOLONE ACETONIDE1 in 1 CARTONOIL16
70752-159-20FLUOCINOLONE ACETONIDE20 mL in 1 BOTTLEOIL206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-159FLUOCINOLONE ACETONIDE OIL [QUAGEN PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 2 package rows20230227_2bcea813-d629-42c5-8953-fa231b4cbf58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionPSN7954bdec-1b75-41d1-8c19-500eceaf6655102
1191299fluocinolone acetonide 0.1 MG/ML Otic SolutionSCD7954bdec-1b75-41d1-8c19-500eceaf6655102
1191299fluocinolone acetonide 0.01 % Auricular OilSY7954bdec-1b75-41d1-8c19-500eceaf6655102
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionSY7954bdec-1b75-41d1-8c19-500eceaf6655102
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionPSNf7861aba-f199-4fe4-90cc-bebea55b3b5f100
1191299fluocinolone acetonide 0.1 MG/ML Otic SolutionSCDf7861aba-f199-4fe4-90cc-bebea55b3b5f100
1191299fluocinolone acetonide 0.01 % Auricular OilSYf7861aba-f199-4fe4-90cc-bebea55b3b5f100
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionSYf7861aba-f199-4fe4-90cc-bebea55b3b5f100
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionPSN2bcea813-d629-42c5-8953-fa231b4cbf586
1191299fluocinolone acetonide 0.1 MG/ML Otic SolutionSCD2bcea813-d629-42c5-8953-fa231b4cbf586
1191299fluocinolone acetonide 0.01 % Auricular OilSY2bcea813-d629-42c5-8953-fa231b4cbf586
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionSY2bcea813-d629-42c5-8953-fa231b4cbf586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70752-159-20707520159201 BOTTLE in 1 CARTON (70752-159-20) / 20 mL in 1 BOTTLE1 bottle2021-04-020000-00-00NoNoCurrent